FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
11/27/1990
FDA Enforcement for the week of November 28, 1990
FDA ENFORCEMENT REPORT
FOR NOV. 28, 1990
November 28, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
Product: Fresh Oysters packed in 8 and 16 ounce plastic jars,
10 ounce glass jars, 64 ounce tins and in 1 and 5 gallon
buckets. Recall #F-692-0.
Code: Sell by dates from September 27 to October 16.
Manufacturer: Coast Oyster Company, Bellevue, Washington.
Recalled by: Manufacturer, by letters of September 22 and 24, 1990.
Firm-initiated recall ongoing.
Distribution: Washington state, Texas, Alabama, Florida, Hawaii, Illinois,
Georgia, Nevada, Missouri, Pennsylvania, Michigan, Oklahoma,
Ohio, Virginia.
Maryland, New York, New Mexico, North Carolina, Louisiana.
Quantity: Approximately 4,500 gallons were distributed.
Reason: Product is contaminated with paralytic shellfish toxin.
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Product: Various brands cut green beans in 15-1/2 cans and 16 ounce
cans:
a. "Bi-Rite French Style Green Beans," net wt. 16 oz.,
distributed by Glendale Foods, Inc., Belle Vernon,
Pennsylvania;
b. Exceptional Value Cut Green Beans, in 15 1/2 or 16 oz.
cans., distributed by Gateway Foods, LaCrosse, Wisconsin;
c. "Flav-o-Rite TENDER CUT Green Beans," net wt. 15 1/2 oz.,
distributed by Preferred Products, Inc., Eden Prairie,
Minnesota;
d. "Flav-o-Rite FRENCH STYLE CUT Green Beans," net wt.
15 1/2 oz., distributed by Preferred Products, Eden Prairie,
Minnesota;
e. "Food Club CUT Green Beans," Net. Wt. 16 oz., distributed
by Topco Associates, Inc., Skokie, Illinois;
f. "Food Club FRENCH STYLE Green Beans," net wt. 16 oz.,
distributed by Topco Associates, Inc., Skokie, Illinois;
g. "Food Club WHOLE Green Beans," net wt. 16 oz.,
distributed by Topco Associates, Inc., Skokie, Illinois
h. "Food Club FRENCH STYLE Green Beans NO SALT ADDED," net
wt. 16 oz., distributed by Topco Associates, Inc., Skokie,
Illinois;
i. "Furr's Blue Lake Whole Green Beans," net wt. 16 oz.,
distributed by Furr's, Inc., Lubbock, Texas;
j. Happy Harvest French Style Green Beans, net wt. 15 1/2 or
16 oz., distributed by Aldi, Inc., Batavia, IL;
k. "IGA GREEN BEANS FANCY CUT BLUE LAKE," net wt. 16 oz.,
distributed by IGA, Inc., Chicago, Illinois;
l. "IGA GREEN BEANS FRENCH STYLE," net wt. 16 oz.,
distributed by IGA, Inc., Chicago, Illinois;
m. "IGA GREEN BEANS WHOLE," net wt. 15 1/2 oz., distributed
by IGA, Inc., Chicago, Illinois;
n. "Lady Lee WHOLE Green Beans," net wt. 16 oz.,
distributed by LKS Products, Inc., General Office, Dublin,
California;
o. "Lakeside CUT GREEN BEANS," net wt. 15 1/2 oz.,
distributed by The Lakeside Packing Company, Monitowoc,
Wisconsin;
p. "MEIJER WHOLE Green Beans BLUE LAKE," net wt. 16 oz.,
distributed by Meijer Inc., Grand Rapids, Michigan;
q. "NATURE'S BEST CUT GREEEN BEANS," net wt. 16 oz.,
distributed by Wetterau, Inc., Hazelwood, Missouri;
r. "NATURE'S BEST FRENCH STYLE GREEN BEANS," net wt. 16 oz.,
distributed by Wetterau, Inc., Hazelwood, Missouri;
s. "PS Whole green beans," net wt. 15 1/2 oz., distributed
by Purity Supreme Supermarkets, North Billerica,
Massaachusetts;
t. "RAINBOW MIXED SHORT CUT & CUT GREEN BEANS," net wt. 15
1/2 oz., distributed by Fleming Companies, Inc., Oklahoma
City, Oklahoma;
u. "Schnuks CUT Green Beans," net wt. 16 oz., distributed
by Schnuck Markets, Inc., Bridgeton, Missouri;
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v. "Schnucks FRENCH STYLE Green Beans," net wt. 16 oz.,
distributed by Schnuck Markets, Inc., Bridgeton, Missouri;
w. "Schnucks FRENCH STYLE Green Beans NO SALT ADDED," net
wt. 16 oz., distributed by Schnuck Markets, Inc., Bridgeton,
Missouri;
x. Shurfine No Salt French Style Green Beans, net wt. 16 oz,
distributed by Shurfine-Central Corporation, Northlake,
Illinois;
y. "SKAGGS ALPHA BETA Cut Green Beans," net wt. 16 oz.,
distributed by American Stores, Newport Beach, California;
z. Staff GRADE A FANCY French Style Green Beans," net wt.
15 1/2 oz., distributed by Staff Supermarket Associates,
Inc., Norcross, Georgia;
aa. "SUPER VALU tender cut green beans," net wt. 15 1/2
oz., distributed by Super Valu Stores, Inc., Eden Prairie,
Minnesota;
bb. "Thorofare CUT GREEN BEANS," net wt. 15 1/2 oz.,
distributed by Thorofare Marketing, San Jose, California;
cc. "Why PAY More? cut green BEANS," net wt. 16 oz.,
distributed by LANECO, INC., Easton, Pennsylvania.
Recall #F-712-0.
Code: Codes embossed on one of the can ends:
a. GFLZC/28020 and GFLZC/18020
b. GECJC/18180
c. GCLJC/18110 and GCLJC/28010
d. GFCZC/18170, GF2ZC/38220 and GF3ZC/28220
e. GCLJC/18090 and GCLJC/28110
f. GFCZC/28170, GFCZC/28180, GFLZC/18020 and GFCZC/18170
g. GWCYC/28180
h. GFDZC/28070
i. GWLYC/28020
j. GFLZC/28010
k. GCLJC/18090 and GC3JC/28220
l. GFLZC/28020
m. GWLYC/18110
n. GWLYC/18100
o. GCLJC/18090
p. GWCYC/28180
q. GCLJC/28010, GCLJC/18020 and GECJC/18180
r. GFLZC/28020 and GFLZC/28010
s. GWLYC/18110 and GWLYC/18100
t. GSLJC/18070, GSLJC/28010, GSCJC/18180, GSLJC/28130,
GSLJC/18130, GSLJC/18140
u. GCLJC/28110
v. GFLZC/28110 and GFLZC/18110
w. GFLZC/28110
x. GFDZC/28070
y. GC3JC/48220 and GC3JC/28220
z. GFLZC/28020
aa. GCLJC/18110
bb. GDLJC/18020, GCLJC/18090 and GDLJC/18130
cc. GECJC/18180
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Manufacturer: Lakeside Packing Company, Manitowoc, Wisconsin.
Recalled by: Manufacturer, by telephone September 14, 1990 followed
by press releases of September 15 and 22, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 28,305 cases (24 cans/case) were distributed.
Reason: Hermetically sealed cans bypassed the retort process.
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Product: Teenage Mutant Ninja Turtles Peanut Butter Graham Cookies,
in 11 ounce boxes. Recall #F-005-1.
Code: All boxes with "Turtle Tales" on the back panel.
Lot numbers: 22001, 21111, 21211, 22711, 30211, 30311,
31011, 32411, 31921, 32021.
Manufacturer: Crescent Baking Company, Davenport, Iowa.
Recalled by: Delicious Cookie Company, Des Plaines, Illinois
(distributor), by telephone October 18, 1990. Firm-
initiated field correction (relabeling) ongoing.
Distribution: Nationwide.
Quantity: 323,604 cases (12 boxes/case) were distributed; firm
estimates 20 percent remains on market.
Reason: Product contains peanuts which are not listed in the
ingredient statement.
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Product: (a) Frozen Special Crabmeat, in 5 pound plastic bags;
(b) Fresh Machine Picked Claw Crabmeat in 1 pound plastic
cups and 5 pound plastic bags. Recall #F-006/007-1.
Code: (a) Not coded; (b) "E" on bottom of the container.
Manufacturer: RCV Seafood Corporation, Morattico, Virginia.
Recalled by: Manufacturer, by telephone October 4-5, 1990. Firm-
initiated recall ongoing.
Distribution: Virginia, Maryland.
Quantity: (a) 239 bags; (b) 75 one pound cups and 163 five pound
bags were distributed; firm estimates none remains on
market.
Reason: Product was contaminated with Listeria monocytogenes.
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Product: (a) Fresh Backfin Crabmeat; (b) Fresh Regular Crabmeat;
(c) Fresh Special Crabmeat, in 1 pound plastic containers
and/or 5 pound plastic bags. Recall #F-008/010-1.
Code: Not coded.
Manufacturer: RCV Seafood, Inc., Morattico, Virginia.
Recalled by: Manufacturer, by telephone August 29, 1990. Firm-
initiated recall ongoing.
Distribution: Virginia, Maryland, Washington, D.C.
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Quantity: 1,250 pounds were distributed; firm estimates none
remains on the market.
Reason: Products were contaminated with Listeria monocytogenes.
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Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-033/036-1.
Code: Unit numbers: (a) 0152248, 0136751, 0137303;
(b) 0152248, 0137303; (c) 0137303; (d) 0152248, 0136751.
Manufacturer: Community Blood Center of Louisiana, Inc., Baton Rouge,
Louisiana.
Recalled by: Manufacturer, by letter April 1990. Firm-initiated
recall ongoing.
Distribution: Florida, Louisiana, Missouri, Indiana, Colorado.
Quantity: (a) 3 units; (b) 2 units; (c) 1 unit; (d) 2 units.
Reason: Blood components which were repeatably reactive
for the antibody to the hepatitis B surface antigen (HBsAg)
or collected from donors who previously tested
repeatably reactive for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1), were
distributed.
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Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma. Recall #B-044/046-1.
Code: Unit numbers: (a) 50305, 51093, 52314, 52937, 52976, 53491;
(b) 53491; (c) 50305, 51093, 52314, 53491.
Manufacturer: Metropolitan Washington Blood Bank, Inc., Silver Spring,
Maryland.
Recalled by: Manufacturer, by telephone on or before March 22, 1990 and
by letters dated March 1, 1990, May 11, 1990 and June 6,
1990. Firm-initiated recall ongoing.
Distribution: Washington, D.C., Maryland, Virginia.
Qiantity: (a) 6 units; (b) 1 unit; (c) 4 units.
Reason: Units which were 1) untested for the antibody to the
human immunodeficiency virus (anti-HIV-1) and the
antibody to the human T-lymphotropic virus (anti-HTLV-1),
2) initially reactive for the hepatitis B surface antigen
(HBsAg), or 3) repeatably reactive for HBsAg, were
distributed.
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Class III -
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-037/039-1.
Code: Unit numbers: 0136843, 0136832.
Manufacturer: Community Blood Center of Louisiana, Inc., Baton Rouge,
Louisiana.
Recalled by: Manufacturer, by letter April 1990. Firm-initiated
recall complete.
Distribution: Florida, Louisiana, Missouri, Indiana, Colorado.
Quantity: 2 units of each component.
Reason: Blood components which were repeatably reactive
for the antibody to the hepatitis B surface antigen (HBsAg)
or collected from donors who previously tested
repeatably reactive for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1), were
distributed.
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Product: Red Blood Cells. Recall #B-043-1.
Code: Unit #3113914.
Manufacturer: Carter Blood Center, Fort Worth, Texas.
Recalled by: Manufacturer, by telephone June 22, 1990. Firm-initiated
recall complete.
Distribution: Texas.
Quantity: 1 unit.
Reason: A unit of Red Blood Cells labeled with an incorrect
expiration date was distributed.
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Product: Platelets. Recall #B-048-1.
Code: Unit #2510286.
Manufacturer: Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
Recalled by: Manufacturer, by telephone February 15, 1990. Firm-
initiated recall complete.
Distribution: Indiana.
Quantity: 1 unit.
Reason: Product untested for the antibody to the human
immunodeficiency virus (anti-HIV-1) and hepatitis B
surface antigen (HBsAg) was distributed.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Model RC-PBL Beam Limiting X-Ray Device. Recall #Z-082-1.
Code: Serial numbers: 499/98.
Manufacturer: Villa & C., S.P.A., Lassone, Italy.
Recalled by: Amerisys, Itasca, Illinois (importer). FDA approved the
firm's corrective action plan October 18, 1990.
Firm-initiated field correction complete.
Distribution: Ohio.
Quantity: 1 unit was distributed and has been corrected.
Reason: The override capability is not in the form of a "capture
key".
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Product: Becton Dickinson 60 cc Luer-Lok Syringes, a general
purpose syringe used with or without infusion systems.
Recall #Z-084-1.
Code: Reorder #9663, lot numbers: 9L646, 9M601, 9M603, 9M605,
9M607, 9M609, 0A616, 0A618, 0A619, 0A621, 0A623, 0A624,
0A626, 0A628, 0A630, 0B633, 0B634, 0B635, 0B638, 0B644,
0B646, 0B648, 0C603, 0C605, 0C607, 0C609, 0C661.
Manufacturer: Becton Dickinson and Company, Columbus, Nebraska.
Recalled by: Becton Dickinson & Company, Rutherford, New Jersey, by
telephone and by letter on or about August 22, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,400,340 units were distributed; firm estimates
1,225,340 units remain on market.
Reason: Increased syringe plunger forces cause inappropriate
pump occlusion alarms. Uneven plunger movement at
low pump infusion rates causes uneven dispensing of liquid.
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Product: Sterile burn dressing and catheter dressing trays:
(a) Small Burn Dressing Tray, Valley Medical Center,
Sterile, Reorder No. J05054A;
(b) Sterile Hand Burn Dressing Tray, Valley Medical
Center, Reorder No. J05053;
(c) Sterile Dressing Tray, Reorder No. J02001;
(d) Medline Sterile Central Venous Catheter Dressing
Change Tray, Reorder No. J03033. Recall #Z-085/088-1.
Code: Lot numbers: 0H0545; (b) 0H0526, (c) 0H1170 EXP 4/92,
(d) 0H1165 EXP 7/93.
Manufacturer: Medline Custom Sterile Division, Medline Industries, Inc.
Mundelein, Illinois.
Recalled by: Medline Industries, Inc., Mundelein, Illinois, by letter
September 18-20, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 43 cases were distributed; firm estimates 50 percent
remains on the market.
Reason: A reddish-brown greasy residue may form on the surface of
the instruments after ETO sterilization.
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Product: Disposable Stainless Steel Forceps, Scissors,
Hemostats and Needleholder:
(a) 4-1/2" Thumb Forceps, Part No. 11, and Precision
Tip (Insert) Forceps, Part No. 16;
(b) 4-1/2" Sharp-Sharp Suture Removal Scissors, Part
No. 21, 4-1/2" Sharp-Blunt Suture Removal Scissors,
Part No. 22, 4" Facial Littauer, Part No. 24,
5-1/4" General Purpose (Sharp-Blunt) Scissors, Part
No. 30 and Sterling Medical Sharp-Blunt 5-1/4"
Scissors, Part No. SS30;
(c) 5-1/2" Hemostat, Kelly Straight, Part No. 40 and
(d) 4-3/4" Hemostat, "Mosquito" Straight, Part No. 42;
(e) 4-1/2" Needleholder, "Mosquito" Serrated, Part No. 52.
Recall #Z-089/092-1.
Code: All product shipped between 8/8/90 and 9/7/90.
(a) Part #11 - lot numbers: 900808, 900813, 900814, 900816,
900821; Part #16 - lot numbers: 900725, 900726, 900727
900801, 900802, 900803, 900808, 900813, 900814, 900815,
900816, 900817, 900821, 900822, 900823, 900829;
(b) Part #21 - lot numbers 900607, 900608, 900609, 900711,
900712, 900716, 900717, 900730, 900809, 900814;
Part #22 - lot numbers: 900725, 900802, 900803, 900806,
900807, 900808, 900809, 900810, 900813, 900814, 900815,
899816, 900817, 900820, 900821, 900822, 900823, 900824,
899831; Part #24 - lot numbers: 900615, 900717, 900718,
900820; Part #30 - lot numbers: 900814, 900815,
Part #SS30, lot 210, Part #40 - lot numbers: 900808, 900809,
900810, 900813;
(d) Part #42 - lot 900831;
(e) Part #52 - lot numbers 900807, 900808, 900809, 900810.
Manufacturer: Sterling Multi-Products, Inc., Prophetstown, Illinois.
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Recalled by: Manufacturer, by telephone and by letter September 7, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: Part #11 - 28 cartons; Part #16 - 153 cartons;
Part #21 - 53 cartons; Part #22 - 519 cartons;
Part #24 - 20 cartons; Part #30 - 38 cartons;
Part #SS30 - 21 cases; Part #40 - 71 cartons;
Part #42 - 2 cartons; Part #52 - 12 cartons.
Reason: A reddish-brown greasy residue forms on the surface when the
instruments are ETO sterilized.
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Product: N Antiserum to Prealbumin Kit. Recall #Z-103-1.
Code: Catalog #969911.
Kit Lot No. Vial Lot No. EXP Date
20768 155115A 10/91
20854 155115D 1/92
21211 155116A 4/92
21259 155116C 4/92.
Manufacturer: Behringwerke AG Marburg, West Germany.
Recalled by: Behring Diagnostics, Inc., Somerville, New Jersey, by
letter September 18, 1990. Firm initiated recall ongoing.
Distribution: Nationwide.
Quantity: Amounts distributed:
Lot 155115 (A&D) - 393 vials (131 kits);
Lot 155116 (A&C) - 357 vials (119 kits.
Reason: Certain kit lots can yeild erroneously elevated prealbumin
concentration (deviations up to + 35%) when used to assay
some patient specimens.
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Class III
Note: Difco brand of Bacto Salmonella O Antiserum Poly A-I
and Vi, Recall #Z-033/035-1 which appeared in the
November 14, 1990 Enforcement Report should have included
the following control numbers:
Salmonella O Antiserum Poly A-I and Vi -- 781518, 777875;
Salmonella O Antisera Set A-I -- 773473, 765994, 780572;
MinESS Antisera Set II -- 769165.
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VETERINARY PRODUCTS
NONE
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